Praluent

What is Praluent?

Praluent is an injectable prescription medicine used in adults with cardiovascular disease to reduce the risk of heart attack, stroke, and certain types of chest pain conditions (unstable angina) requiring hospitalization. It is also used along with diet, alone or together with other cholesterol-lowering medicines in adults with high blood cholesterol levels called primary hyperlipidemia (including a type of high cholesterol called heterozygous familial hypercholesterolemia), to reduce low-density lipoprotein cholesterol (LDL-C) or bad cholesterol.

It is not known if Praluent is safe and effective in children.

Description

Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa.

PRALUENT is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. PRALUENT 75 mg/mL or 150 mg/mL solution for subcutaneous injection in a single-dose pre-filled pen is supplied in a siliconized 1 mL Type-1 clear glass syringe.

Each 75 mg/mL pre-filled pen contains 75 mg alirocumab, histidine (8 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0.

Each 150 mg/mL pre-filled pen contains 150 mg alirocumab, histidine (6 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0.

Mechanism of Action

Alirocumab is a human monoclonal antibody that binds to proprotein convertase subtilisin kexin type 9 (PCSK9). PCSK9 binds to the low-density lipoprotein (LDL) receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver. By inhibiting the binding of PCSK9 to LDLR, alirocumab increases the number of LDLRs available to clear LDL, thereby lowering LDL-C levels.

Who should not take Praluent?

Do not use Praluent if you are allergic to alirocumab or to any of the ingredients in Praluent. See the end of this leaflet for a complete list of ingredients in Praluent.

What should I tell my healthcare provider before taking Praluent?

Before you start using Praluent, tell your healthcare provider about all your medical conditions, including allergies, and if you:

• are pregnant or plan to become pregnant. It is not known if Praluent will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking Praluent.
  Pregnancy Registry. There is a pregnancy registry for women who take Praluent during pregnancy. The purpose of this registry is to collect information about your health and your baby’s health. You can talk to your healthcare provider or contact 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/Praluent/ to enroll in this registry or get more information.
• are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take Praluent or breastfeed. You should not do both without talking to your healthcare provider first.

Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies.

How should I take Praluent?

• See the detailed “Instructions for Use” that comes with your patient information about the right way to prepare and give your Praluent injections.
• Use Praluent exactly as your healthcare provider tells you to use it.
• Praluent comes as a single-dose (1 time) pre-filled pen (autoinjector), or as a single-dose pre-filled syringe. Your healthcare provider will prescribe the type and dosage that is best for you.
• If your healthcare provider decides that you or a caregiver can give the injections of Praluent, you or your caregiver should receive training on the right way to prepare and administer Praluent. Do not try to inject Praluent until you have been shown the right way by your healthcare provider or nurse.
• Praluent is injected under the skin (subcutaneously) every 2 weeks or every 4 weeks (monthly).
• If your healthcare provider prescribes you the monthly dose, you will give yourself 2 separate injections in a row, using a different syringe or pen for each injection and two different injection sites.
• Do not inject Praluent together with other injectable medicines at the same injection site.
• Always check the label of your pen or syringe to make sure you have the correct medicine and the correct dose of Praluent before each injection.
• If you forget to use Praluent or are not able to take the dose at your regular time, inject your missed dose as soon as you remember, within 7 days. Then, if you inject every 2 weeks take your next dose in 2 weeks from the day you missed your dose or if you inject every 4 weeks take your next dose in 4 weeks from the day you missed your dose. This will put you back on your original schedule.
• If you missed a dose by more than 7 days and you inject every 2 weeks wait until your next scheduled dose to re-start Praluent or if you inject every 4 weeks start a new schedule from the time you remember to take your dose. If you are not sure when to re-start Praluent, ask your healthcare provider or pharmacist.
• If you use more Praluent than you should, talk to your healthcare provider or pharmacist.
• Do not stop using Praluent without talking with your healthcare provider. If you stop using Praluent, your cholesterol levels can increase.

What are the possible side effects of Praluent?

Praluent can cause serious side effects, including:

• allergic reactions. Praluent may cause allergic reactions that can be severe and require treatment in a hospital. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including a severe rash, redness, severe itching, a swollen face, or trouble breathing.

The most common side effects of Praluent include: redness, itching, swelling, or pain/tenderness at the injection site, symptoms of the common cold, and flu or flu-like symptoms.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of Praluent. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Praluent

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Praluent for a condition for which it was not prescribed. Do not give Praluent to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information summarizes the most important information about Praluent. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Praluent that is written for health professionals.

For more information about Praluent, go to www.PRALUENT.com or call 1-844-PRALUENT (1-844-772-5836).

How should I store Praluent?

Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton in order to protect from light. If needed, Praluent may be kept at room temperature up to 77°F (25°C) for a maximum of 30 days in original carton to protect from light. Do not store above 77°F (25°C). After removal from the refrigerator, Praluent must be used within 30 days or discarded.

Do not freeze. Do not expose to extreme heat. Do not shake.

Keep out of reach of children.

What are the ingredients in Praluent?

Active ingredient: alirocumab

Inactive ingredients: histidine, polysorbate 20, sucrose, and Water for Injection, USP.

Label

PRINCIPAL DISPLAY PANEL – 75 MG/ML PEN CARTON

• NDC 61755-020-01
  Rx ONLY
• Praluent®
  alirocumab
  Injection
  75 mg/mL
• One Pre-filled Pen
• For subcutaneous injection only. Single-dose.
• Carton contains: One single-dose pre-filled pen, the Package Insert,
  Patient Information, and Instructions for Use.
• 75 mg/mL
• OPEN
  HERE
• REGENERON

PRINCIPAL DISPLAY PANEL – 150 MG/ML PEN CARTON

• NDC 61755-021-01
  Rx ONLY
• Praluent®
  alirocumab
  Injection
  150 mg/mL
• One Pre-filled Pen
• For subcutaneous injection only. Single-dose.
• Carton contains: One single-dose pre-filled pen, the Package Insert,
  Patient Information, and Instructions for Use.
• 150 mg/mL
• OPEN
  HERE
• REGENERON

SRC: NLM .